Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A Phase 3, Double-masked, Randomized, Controlled Study of KPI-121 0.25% Ophthalmic Suspension Compared to Vehicle In Subjects With Dry Eye Disease (STRIDE 3)

Trial Profile

A Phase 3, Double-masked, Randomized, Controlled Study of KPI-121 0.25% Ophthalmic Suspension Compared to Vehicle In Subjects With Dry Eye Disease (STRIDE 3)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2019

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Loteprednol etabonate (Primary)
  • Indications Dry eyes
  • Focus Registrational; Therapeutic Use
  • Acronyms STRIDE 3
  • Sponsors Kala Pharmaceuticals
  • Most Recent Events

    • 07 Nov 2019 According to a Kala Pharmaceuticals media release, the company is targeting topline data from this trial in the first quarter of 2020 and resubmission of the NDA in the first half of 2020.
    • 08 Aug 2019 According to a Kala Pharmaceuticals media release, the company is targeting topline data from this study by the end of 2019 and resubmission of the NDA during the first half of 2020. The Company believes this resubmission would be subject to a six-month review under the Prescription Drug User Fee Act.
    • 08 Aug 2019 According to a Kala Pharmaceuticals media release, the company received a complete response letter (CRL) from the U.S. (FDA) regarding the Companys new drug application (NDA) for KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease.The FDA indicated that efficacy data from an additional clinical trial will be needed to support a resubmission.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top